R2 and Combination Chemotherapy Versus R and Combination Chemotherapy in Newly Diagnosed Highly Aggressive B-NHL

November 4, 2019 updated by: Wang Xin, Shandong Provincial Hospital

Lenalidomide, Rituximab and Combination Chemotherapy Versus Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Highly Aggressive Non-Hodgkin B-cell Lymphoma

In this study，lenalidomide was added in the first-line treatment in the newly diagnosed highly invasively non-Hodgkin B-cell lymphoma. The R2-CHOP/R2-EPOCH etc was applied compared with the classical R-CHOP/R-EPOCH etc. The investigators tried to explore a more effective and safe treatment regimen for patients with high-risk B-cell lymphoma to improve the patient's poor prognosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Lymphoma has become one of the top ten malignant tumors, of which non-Hodgkin's B-cell lymphoma accounts for the majority. As the classic first-line treatment, the emergence of the R-CHOP program has resulted in clinical cures for more than 1/2 of patients with B-cell lymphoma. But for patients with highly aggressively B cell lymphoma, most of them still suffer from disease recurrences due to R-CHOP treatment alone.

In recent years, with the emergence of various new drugs, many researchers have tried to add new drugs to the classic R-CHOP program as a first-line treatment for non-Hodgkin B-cell lymphoma. As a new type of immunomodulator, lenalidomide was first approved for the treatment of multiple myeloma. In recent years, its role in refractory and relapsed B-cell lymphoma has gradually been recognized.

In 2015, Nowakowski et al. published a clinical study of 64 patients with diffuse large B-cell lymphoma who used R2-CHOP in first-line therapy. It was found that R2-CHOP does not improve R-CHOP in patients with GCB. The effective rate of treatment and the 2-year survival rate of patients, but for patients with non-GCB type DLBCL with poor prognosis, the addition of lenalidomide can greatly improve the remission rate of the disease and improve the poor prognosis of patients.

So, the investigators initiate this study to evaluate the efficacy of R2-CHOP/R2-EPOCH etc in newly diagnosed highly invasively non-Hodgkin B-cell lymphoma.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jin'an, Shandong, China, 250012
        • Recruiting
        • Department of Hematology, Provincial Hospital Affiliated to Shandong University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Newly diagnosed highly aggressively B-Cell Non-Hodgkin's lymphoma (NHL) confirmed by histopathology
  2. The patient has at least ≥1 measurable tumor lesion with a diameter >1.5 cm;
  3. The patient has not undergone systemic chemotherapy or immunotherapy before;
  4. ECOG score ≤ 2 points;
  5. Liver and kidney function meets the following conditions: creatinine clearance rate ≥ 30ml / min, total bilirubin, AST and ALT ≤ 2.5 × ULN;
  6. No history of malignant tumors within 5 years, except for cured carcinomas in situ such as basal cell carcinoma of the skin, cervical cancer, breast cancer, prostate cancer, etc.;
  7. agree to take contraceptive measures during the trial period and within 3 months after the end of the trial;
  8. Patients volunteered to participate in the study and signed informed consent.

Exclusion Criteria:

  1. Serious cardiovascular and other important organs and blood, endocrine system lesions, and other history of malignant tumors;
  2. Severe mental illness;
  3. Pregnant or lactating women and men or women who intend to conceive in the near future;
  4. The expected survival time is less than 6 months;
  5. HBV, HCV or HIV infection or seropositive;
  6. there are active infections;
  7. Allergies or allergies to rituximab;
  8. Compliance or poor follow-up;
  9. Other circumstances that the investigator believes are not suitable for inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: R2-combination chemotherapy

R2-CHOP/CHOPE/DA-EPOCH/HD MTX

R2-CHOP :

lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5

R2-DA-EPOCH:

lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5;

R2-HD MTX:

lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1
Drug: R2-combination chemotherapy

R2-CHOP/CHOPE/DA-EPOCH/HD MTX

R2-CHOP :

lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5

R2-DA-EPOCH:

lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5;

R2-HD MTX:

lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1
Active Comparator: R-combination chemotherapy

R-CHOP/CHOPE/DA-EPOCH/HD MTX

R-CHOP :

Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5

R-DA-EPOCH:

Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5;

R-HD MTX:

Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1
Drug: R-combination chemotherapy

R-CHOP/CHOPE/DA-EPOCH/HD MTX

R-CHOP :

Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5

R-DA-EPOCH:

Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5;

R-HD MTX:

Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate after 3 cycles
Time Frame: at the end of 3 cycles( each cycle is 21 days)
Percentage of patients with complete remission （CR）or partial remission （PR）
at the end of 3 cycles( each cycle is 21 days)
Overall Response Rate after 6 cycles
Time Frame: at the end of 6 cycles( each cycle is 21 days)
Percentage of patients with complete remission （CR）or partial remission （PR）
at the end of 6 cycles( each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival（PFS）
Time Frame: 2 years
Time from enrollment to tumor progression or death
2 years
overall survival（OS）
Time Frame: 2 years
Time from enrollment to death
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Provincial Hospital

Investigators

  • Principal Investigator: Xin Wang, MD,PhD, Shandong Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2019

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

October 27, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 4, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShangdongPH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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